Simultaneous determination of acetyl salicylic acid (ACA) and salicylic acid (SA) in marketed enteric coated tablet dosage forms using UPLC method

Abstract Acetyl salicylic acid (ACA) is available as an over-the-counter medicine used as an analgesic, anti-inflammatory, and antipyretic. In this article, a simple, sensitive, rapid, and precise ultra performance liquid chromatography (UPLC) analytical method was proposed for the simultaneous determination of Acetyl salicylic acid (ACA) and Salicylic acid (SA) in marketed enteric-coated tablet dosage forms. The current UPLC method was developed on Waters UPLC (Waters, Milford, USA), C8 column and column oven system controller was maintained at a temperature of 35 ± 5 °C. The mobile phase consists of the mixture of methanol: H 2 O: Orthophosphoric acid in water (OPA 0.1%) (60:30:10, v/v/v) for the simultaneous determination of ACA and SA in marketed enteric-coated tablet dosage forms. The maximum absorbance of ACA and SA was found to be 227.3 nm. The current UPLC method was validated as per the ICH guidelines. The developed UPLC method was found to be linear 62.5–312.5 and 56–280 ng mL −1 for ACA and SA, respectively. The LOD and LOQ were found to be 0.022 and 0.068 ng mL −1 for ACA, respectively, and 0.068 and 0.073 ng mL −1 , for SA respectively. The mean retention times of 1.012 ± 0.00 and 1.254 ± 0.00 were observed for ACA and SA, respectively. Moreover, the current UPLC method for the simultaneous determination of ACA and SA was rapid, accurate, precise, robust and highly sensitive. These observations demonstrated that ACA and SA in the marketed enteric-coated tablet dosage forms can be consistently analyzed by using the current UPLC method.